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# Aeskuslides nDNA (Crithidia Luciliae) Assay Cleared
- URL: https://www.fdaweb.com/aeskuslides-ndna-crithidia-luciliae-assay-cleared/
- Published: 2018-04-04T12:00:00.000Z
- Updated: 2026-09-14T23:57:16.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141150

FDA has cleared an Aesku Group 510(k) for its [Aeskuslides nDNA (Crithidia luciliae)](https://www.aesku.com/index.php/diagnostics/aeskuslides-ifa-test-kits/autoimmunity-ifa/itemlist/category/39-ndna-crithidia-luciliae-fda-cleared-products?ref=fdaweb.com) assay and its use on the company’s new [Helios Automated IFA System](https://www.aesku.com/index.php/automation/helios-fully-automated-ifa-processor?ref=fdaweb.com). The kit is the second clearance for its immunofluorescence assay on the Helios, after its ANA HEp-2 cleared in 2016\. Immunofluorescence assays are considered the gold standard for systemic autoimmune disease screening, the company says. Helios is designed to improve traceability and turnaround time, and it eliminates the subjectivity and labor-intensiveness of standard immunofluorescence assays, it says.